FDA grants Breakthrough Therapy Designation to AstraZeneca's Imfinzi for lung cancer

The US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to AstraZeneca's immunotherapy drug Imfinzi (durvalumab). This designation is reserved for experimental medicines intended to treat serious conditions where early clinical evidence indicates a substantial improvement over current standard therapies.

The designation focuses on patients with locally-advanced, unresectable non-small cell lung cancer (NSCLC) who have not progressed following platinum-based chemotherapy concurrent with radiation therapy. Currently, clinical practice for these patients is limited to active monitoring after initial treatment, with a high probability that the cancer will progress to metastatic disease within a year.

AstraZeneca reported that the designation is supported by interim data from the Phase III PACIFIC trial. According to the company, this marks the fourth Breakthrough Therapy Designation received for one of its oncology medicines in the last three years, highlighting the company’s efforts to compete in the immuno-oncology market.

Imfinzi functions by blocking the PD-L1 protein, which tumors use to evade the immune system. The company continues to evaluate the drug in multiple late-stage clinical trials, exploring its efficacy both as a monotherapy and in combination with other treatments across various stages of lung cancer and other malignancies.